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Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma

Sponsor
Agenus Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00039000
Collaborator
(none)
350
Enrollment
77
Locations
45
Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary goal of this study is to determine if people with metastatic melanoma who receive Heat Shock Protein-Peptide Complex - 96 (HSPPC-96 or Oncophage) after surgery live longer than people who may or may not have surgery but who receive conventional chemotherapy including IL-2/DTIC. A second goal is to determine the safety and frequency of side effects in subjects who receive therapy with HSPPC-96.

Condition or Disease Intervention/Treatment Phase
  • Drug: HSPPC-96 or Oncophage
 Phase 3

Detailed Description

Primary Objective:
  • To determine whether subjects with stage IV melanoma randomized to HSPPC-96 have longer survival than subjects randomized to physician's choice including interleukin-2 and/or dacarbazine/temozolomide and/or complete tumor resection.
Secondary Objective:
  • To determine frequency of adverse events in subjects randomized to HSPPC-96.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus Physician's Choice Including Interleukin-2 and/or Dacarbazine/Temozolomide-based Therapy and/or Complete Tumor Resection in Stage IV Melanoma
Study Start Date :
Mar 1, 2002
Actual Primary Completion Date :
Dec 1, 2005
Actual Study Completion Date :
Dec 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Eligibility Assessment:

    (The following assessments must be obtained within three weeks prior to randomization into the study)

    • Medical history and physical examination (including EGOG score, evidence of immunosuppression);

    • CT/MRI of the chest, abdomen and pelvis;

    • Clinical examination;

    • CT/MRI of the brain;

    • Complete Blood Count with differential including platelets;

    • Electrolytes (Na, Cl, K, HCO3, Ca, Mg, PO4);

    • Renal function tests (BUN and creatinine);

    • Liver function tests (bilirubin, AST, ALT);

    • Serum pregnancy test for all women of childbearing potential.

    Inclusion Criteria:

    • Stage IV Melanoma (AJCC);

    • No prior therapy for stage IV melanoma;

    • No prior therapy with interleukin-2 and/or dacarbazine/temozolomide within the past 12 months prior to study entry;

    • Candidate for surgical resection of some/all sites of melanoma and expected to obtain greater tan or equal to 7 grams of viable cancer tissue (in aggregate), which is equivalent to a greater than or equal to 2 cm lesion on CT/MRI or clinical examination;

    • No brain metastases;

    • ECOG score 0 or 1;

    • Adequate cardiac function;

    • Adequate hematopoietic, liver and renal function;

    • Female subjects of child-bearing potential must agree to use contraception during the study

    • Signed written informed consent.

    Exclusion Criteria:

    • Mucosal or ocular melanomas;

    • Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer;

    • Primary or secondary immunodeficiency, in the opinion of the investigator (including immunosuppressive disease, or use of systemic corticosteroids or other immunosuppressive medications);

    • Prior splenectomy;

    • Uncontrolled infection or other serious medical illnesses;

    • Women who are pregnant or breast-feeding;

    • Subjects participating in any other studies requiring administration of an investigational drug/biologic agent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States
    2 Scottsdale Arizona United States
    3 Berkeley California United States
    4 Los Angeles California United States
    5 Stanford California United States
    6 Vista California United States
    7 Denver Colorado United States
    8 Farmington Connecticut United States
    9 Jacksonville Florida United States
    10 Lakeland Florida United States
    11 Miami Beach Florida United States
    12 Atlanta Georgia United States
    13 Chicago Illinois United States
    14 Park Ridge Illinois United States
    15 Kansas City Kansas United States
    16 Louisville Kentucky United States
    17 Baltimore Maryland United States
    18 Boston Massachusetts United States
    19 Robbinsdale Minnesota United States
    20 Rochester Minnesota United States
    21 Columbia Missouri United States
    22 St. Louis Missouri United States
    23 Lebanon New Hampshire United States
    24 New Brunswick New Jersey United States
    25 New York City New York United States
    26 Cincinnati Ohio United States
    27 Cleveland Ohio United States
    28 Tulsa Oklahoma United States
    29 Portland Oregon United States
    30 Philadelphia Pennsylvania United States
    31 Pittsburgh Pennsylvania United States
    32 Knoxville Tennessee United States
    33 Dallas Texas United States
    34 Houston Texas United States
    35 Madison Wisconsin United States
    36 Adelaide Australia
    37 Camperdown Australia
    38 Melbourne Australia
    39 Newcastle Australia
    40 Wentworthville Australia
    41 Budapest Hungary
    42 Debrecen Hungary
    43 Pecs Hungary
    44 Szeged Hungary
    45 Aviano Italy
    46 Genova Italy
    47 Milan Italy
    48 Rimini Italy
    49 Bialystock Poland
    50 Bydgoszcz Poland
    51 Krakow Poland
    52 Arkhangelsk Russian Federation
    53 Chelyabinsk Russian Federation
    54 Kazan Russian Federation
    55 Krasnodar Russian Federation
    56 Moscow Russian Federation
    57 Novosibirsk Russian Federation
    58 Ryazan Russian Federation
    59 Samara Russian Federation
    60 St. Petersburg Russian Federation
    61 Stavropol Russian Federation
    62 Voronezh Russian Federation
    63 Gothenburg Sweden
    64 Lund Sweden
    65 Vaxjo Sweden
    66 Dnepropetrovsk Ukraine
    67 Donetsk Ukraine
    68 Ivano-Frankovsk Ukraine
    69 Kiev Ukraine
    70 Krivoy Rog Ukraine
    71 Lviv Ukraine
    72 Odessa Ukraine
    73 Uzhgorod Ukraine
    74 Vinnitsa Ukraine
    75 Leeds United Kingdom
    76 London United Kingdom
    77 Manchester United Kingdom

    Sponsors and Collaborators

    • Agenus Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Agenus Inc.
    ClinicalTrials.gov Identifier:
    NCT00039000
    Other Study ID Numbers:
    • C-100-21
    • NCT00047359
    First Posted:
    Jun 10, 2002
    Last Update Posted:
    Sep 7, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by Agenus Inc.
    Immunotherapy, Cancer, Melanoma, Skin Cancer, tumor
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Sep 7, 2012